WO2005062216A1 - A temperature controlled delivery system - Google Patents

Abstract

A method for tracking and tracing products comprising one or more units and providing temperature controlled delivery of the products from storage area to end user. The method also providing realtime recall of the product to an individual unit level during any stage of the method. Each product being ascribed a unique EAN barcode and an end-user, the details of the end-user optionally being stored in a unique barcode thereby ensuring that each product is delivered to the correct end-user and that movements through the steps of the method are traceable. Comprised product can be removed or recalled at any stage throughout the steps of the method due to the unique barcode. Product close to expiry can be highlighted and rotated to high use end-users. Individual end-users have facility to scan product post administration which updates the central computer system.

Description

A TEMPERATURE CONTROLLED DELIVERY SYSTEM

The present invention provides a method and apparatus for temperature controlled delivery of products, in particular for use in delivering temperature sensitive products such as, but not limited to, blood factor concentrates, vaccines and other pharmaceutical products.

In recent years there has been growing concern surrounding the maintenance of quality in relation to cold-chain storage and distribution of pharmaceutical products especially specialist biological pharmaceutical products such as blood factor concentrates and vaccines.

Historically, supplies of such products were transported in bulk from pharmaceutical companies to a national centre and from there, dispatched to either hospitals or patients. This has resulted in much inefficiency. An audit in 2001 by The Medicines Control Agency (MCA) in the United Kingdom highlighted areas of critical deficiencies. These areas included temperature control of pharmaceutical and biological products, monitoring of said products when in cold-chain storage and subsequently cold-chain distribution of such products. These deficiencies comprised more than one-third of all critical deficiencies within the United Kingdom.

Validation is important in most industries, but is essential in the pharmaceutical and biological industries. It is absolutely necessary to demonstrate accurately and reproducibly that the pharmaceutical products supplied to the end users are of the highest standard and that the condition of the pharmaceutical products have not deteriorated in any way from production through to use by the end users. Equally, it is important to provide a detailed traceable account of each product from manufacture to use. This ensures that if an individual product within a batch or an entire batch is contaminated or has deteriorated in quality, that a record exists which facilitates a comprehensive recall process, in addition the record also indicates where the fault may have occurred. Furthermore, the record provides a means of identifying the source and batch of the contaminated product and/or other batches of the contaminated product that may have emanated from the source. Once identified the other products and/or source can be tested for similar contamination/deterioration. Previous systems have failed to provide any such means or assurances.

Furthermore, it is of utmost importance to maintain accurate records to accompany the pharmaceutical products that enter into the cold-chain storage/distribution system. Currently there is a significant lack of quality standards concerning the best practice relating to tracking and tracing of cold-chain pharmaceutical or biological products. The companies involved in the pharmaceutical or biological supply chain are constantly challenged to maintain good practices so that the products can be shipped to market at the correct temperature and be of the highest standard whilst demonstrating traceability and validity to the increasingly vigilant regulatory bodies.

The current methods employed do not provide such assurances and result in significant wastage due to poor administrative and implementation practices.

It is an object of the present invention to seek to alleviate the aforementioned problems.

The following terms and abbreviations will be used throughout the specification:

AS2 - Applicability Statement 2

EAN - European Article Numbering.

UCC - Uniform Code Council.

Barcode - The Barcode is the physical manifestation of codes to standards such as (EAN) (EANUCC.128 or UCC.RSS - the International and Uniform Code Council Standard).

Central Distribution, Tracking and Control System (CDTCS) This is the name used to generally identify the system of the present invention. Global Service Relationship Number (GSRN) [EAN CODE]

The Global Service Relationship Number (GSRN) is used to identify the relationship between entities i.e. patient/hospital/treatment e.g. a GSRN is used to identify a particular Patient and Treatment combination.

The GSRN may change as a result of a change in Clinician, Hospital or Treatment.

Global Location Number (GLN) [EAN CODE]

The Global Location Number is used to identify entities such as physical locations (e.g. Warehouse, Van), Person (e.g. Clinicians and Consultants), Delivery Points (e.g. Patient Home, Company or Organisation).

Global Trade Item Number (GTIN) [EAN CODE]

The Global Trade Item Number (GTIN) is used to uniquely identify Trade Items (Products).

GPRS - General Packet Radio Service (GPRS) enabled networks offer "always on" services.

GPS - Global Positioning System is a worldwide navigation system formed from a constellation of satellites and their ground stations.

IT - Information Technology.

Vial Box Serial Number (VBSN)

The Vial Box Serial Number is a unique individual record for each product box/tote box.

Serial Shipping Container Code (SSCC) [EAN CODE]

The Serial Shipping Container Code (SSCC) is used to identify a shipping unit (e.g. Carton, Tote Box etc.).

Tote Box - Container box for packing a number of Vial Boxes. Patient Master GSRN (PMGSRN)

Each Patient has a unique Identity Number, which will be associated with each particular patient throughout their lifetime. This is described as the Patient "Master" Global Service Relationship Number (PMGSRN). This number will remain static for every Patient. This is not to be confused with other GSRN's which will include Patient/Treatment and which will be subject to change.

Average Cost - Means the average cost of the product based on the quantities delivered and the costs per delivery.

Change Orders - This refers to any new requirement which will accordingly result in a change in the standing order.

Cold-Chain/Cold-Chain System - Relates to the validated and verifiable temperature monitoring (2°C-8°C) of products through the Supply Chain System.

FIFO - First In First Out (FIFO) is a recognised stock control process.

PAS - Patient Administration System.

PDA - Personal Digital Assistant.

POD - Proof of Delivery.

QC - Quality Control

RFID - Radio Frequency Identification.

RP - The Authorised and Responsible Person.

Shelf Life - The period for which the product is suitable for use. Specific Order Requests - Additional or special requirements, which are temporary or once off order requests.

Standard Data Carriers - The information represented by the Global Trade Item Number (GTD ), Global Location Number (GLN) and Serial Shipping Container Code (SSCC) are encoded in Barcodes. Scanners then read these Barcodes and transmit this information to a computer.

Standard Electronic Messages - Identification numbers are also used in electronic data interchange (EDI) messages to improve the speed and accuracy of data, which is sent between trading partners. The European Article Number (EAN) standard for electronic messages is called EANCOM.

Prescription Standing Orders - The usual or standing delivery order requirement.

The present invention provides a method of tracking and tracing a product comprising one or more units and providing temperature controlled delivery of the product from a storage area to an end-user and providing the capability of realtime recall of the product to individual unit level at any stage during the steps of the method, the method comprising the steps of: storing products in a storage area at the required range of temperatures; importing details of the stored products to a stock file on a computer; accepting orders for stored products from an end-user; importing details of each order into an order file on the computer; generating a unique serial number for each individual unit within a batch; relating order details in order file to stored product information in stock file on the computer; generating a delivery order notice which includes product information from stock file on the computer; issuing stored product and the delivery order notice from the storage area; placing issued product and the delivery order notice into a refrigerated vehicle with temperatures at the required range, the refrigerated vehicle having a global positioning system (GPS); importing information on the delivery order notice electronically into a general packet radio service (GPRS) communication system; delivering issued product to an end user or other location from the refrigerated vehicle; and updating the stock file and/or the order file on the computer from GPRS communication system once delivery of issued goods has been completed.

Advantageously the products are received from either the pharmaceutical companies or the Central Authority responsible for issuing pharmaceutical products.

Advantageously the required range of temperatures are 2°C - 8°C. The method of the invention is easily adapted to any temperature range required by a person skilled in the art.

Advantageously, the method of the invention provides a secure means for tracking and tracing products from the storage area to the end-user. Conveniently the method of the invention can also be used to recall products at any stage during the steps of the method, should a problem with a particular product be detected. This can ensure that quality control and product accountability are present at all stages throughout the method of the invention.

Ideally, international standards [such as those devised by EAN, The International Standards Organisation] are used to uniquely identify each product. For example, each product can be identified by means of the EAN.UCC (The International and Uniform Code Council) system. This system is a barcode system which is used as a basis for encoding relevant data. Optionally the barcode will include a Global Trade Item Number (GTIN) which will identify the product name and strength and at least one of the following pieces of information, quantity information, batch information, and expiration information. Ideally, each product is given a first barcode at the point of manufacture. Conveniently, the barcode assigned to each product when produced contains the Global Trade Item Number (GTIN). Optionally, the barcode may also contain other information including batch and expiration information.

Preferably, when the product is delivered to the storage area, the barcode of each item is scanned for electronic entry of product information into the stock file. Alternatively the information can be entered manually into the stock file on the computer. Conveniently the storage area comprises a processing area and a storage refrigerator. Advantageously entering product information onto the computer takes place in the processing area.

Ideally, as each product item is logged into the stock file a second barcode is generated identifying the serial number of each product within a batch of products. For example, if there are ten product items within a batch, each product is assigned a number, one, two, and so forth. Ideally each product is tested in the processing area to establish its core temperature prior to storage and/or distribution.

Advantageously, each product, once logged and tested, is placed in the storage refrigerator. Ideally the storage area operates with a plurality of paired refrigerator units. Preferably, the refrigerator units are powered by mains electricity and are backed up by a generator which will start immediately should the electricity supply fail. Ideally, monitoring equipment is used to ensure the temperature of the storage area remains within the desired range of temperatures. Conveniently, the monitoring equipment is connected to a computerised control unit. Advantageously, the computerised control unit contains a dial- out unit that can dial a series of numbers to alert personnel in the event of alarm activation and/or electricity supply failure. Preferably, the monitoring equipment is also connected to the generator in the event of electricity supply failure. Advantageously, the dial-out unit also enables personnel to access the monitoring equipment for real-time external monitoring.

Advantageously, the invention uses network and telecommunication systems that facilitate a secure environment which in turn enables a secure method of data transmission. Ideally, a central computer within the network is used to store the product and order information in stock and order files respectively. Advantageously, this information can be accessed as required by other computers on the network. Ideally, the quantity of information available to other computers is limited as desired by the central computer. Conveniently, other pertinent information can also be stored on the central computer, for example, patient record files, possible substitutes for some or all of the products and patient prescriptions.

Preferably, the General Packet Radio Service (GPRS) system within the refrigerated vehicle is a mobile device. Optionally, this may be a handheld GPRS device.

In one embodiment of invention, the method of the invention further includes the steps of: producing patient prescriptions from a doctor or a hospital electronic format; and forwarding the electronic prescription as an order to the temperature controlled system.

Conveniently, in this embodiment of the invention, when the order is dispatched, the order can be delivered to either the pharmacist, hospital, prescribing physician or a location from which the patient can collect it or alternatively, the order can be delivered directly to the patient. Preferably, in this embodiment of the invention when the product is issued from the storage area, a dispensing label is produced and attached to an individual product. A Serial Shipping Container Code (SSCC) barcode label is produced and attached to the outer delivery/tote box. Optionally, the SSCC barcode label contains information such as the Global Relationship Service Number (GSRN) which identifies the relationship between two separate entities such as the patient and either the hospital or doctor and/or the patient and the product. Any other appropriate information may also be included in the SSCC barcode label including GTIN and GLN.

Advantageously, the delivery location can be reassigned and relocated at any stage during the delivery process. Ideally, if the end-user has to change location the information is relayed electronically to the central computer which in turn relays the information to the driver of the vehicle. Advantageously, the information can be relayed to the GRPS system within the refrigerated vehicle. The driver of the refrigerated vehicle can react accordingly and the product can be delivered to the correct location.

Preferably, once all deliveries have been completed and the GRPS system has updated the stock and/or order files on the central computer, the central computer then electronically advises the appropriate authorities that the delivery cycle has been completed. For example, the central computer may alert the doctor or hospital that initially issued the prescription that the patient or pharmacist had received the order. Alternatively, the central computer might inform the Central Authority that the delivery had been successfully completed to aid validation and quality control. The central computer is also able to update clinical records.

Advantageously, the method of the invention can be licensed by the Central Authority for use thereby providing a means of promoting assurance, validation and quality in the distribution of products that require strict temperature control.

Conveniently, the method of the invention further comprises the step of delivering the order directly to a patient or to a Pharmacist from whom the patient can collect it.

Alternatively, the method includes the step of delivering issued product from the refrigerated vehicle to an end user in a hospital, the hospital being provided with a hospital storage area at the required range of temperatures and the hospital having designated locations where each designated location has an assigned Global Location Number (GLN).

Preferably, the in-hospital designated locations include a refrigerated area, wards, product quarantine area, intensive care unit (ICU) and Accident and Emergency (Casualty) Department. Advantageously, the system scans the bar code at point of administration thereby ensuring the correct product is administered to the right patient.

Advantageously, the method of the invention further includes the step of storing on the central computer information on the patient record including patient Master Global Service Relation Number (GSRN), name and address and date of birth of the patient.

Ideally, when a patient presents at the hospital, the appropriate patient record is retrieved from the computer including the patient Master Global Service Relationship Number (GSRN).

Preferably, the method includes the step of scanning the bar code on the vial box(es) selected for the patient's treatment and storing the details-on the computer.

Ideally, the refrigerated vehicle in the method of the present invention comprises a refrigeration area operable within a required temperature range by at least two refrigeration units, first refrigeration unit operable by the vehicle's power supply and a second refrigeration unit operable by both a battery and mains electrical supply, at least one detection probe for monitoring the temperature of the refrigeration area, a monitoring unit for recording and displaying the temperature data from the detection probe, and an alarm unit is triggerable when the temperature of the refrigeration area reaches a pre-set minimum or maximum temperature on the monitoring unit.

Preferably, the refrigeration vehicle comprises a primary refrigeration unit and the second refrigeration unit comprises an auxiliary refrigeration unit. Advantageously, the refrigeration vehicle comprises a plurality of air-temperature probes and at least one product probe.

Ideally, the refrigeration vehicle comprises a temperature probe packaged as a product and placed in a product container thereby mimicking a real product.

Conveniently, the refrigeration vehicle comprises at least one alarm triggerable when the temperature of the refrigeration area reaches the pre-set minimum or maximum temperature within the required operable temperature range.

Advantageously, the alarm unit is triggerable when the temperature of the refrigeration area reaches within 1°C above the minimum temperature within the required temperature range or 1°C below the maximum temperature within the required temperature range.

Ideally, the alarm unit further comprises a second alarm which is triggerable when the temperature of the refrigeration area reaches the minimum temperature within the required temperature range or the maximum temperature within the required temperature range.

Preferably, the Global Positioning System (GPS) on the refrigeration vehicle facilitates remote monitoring of the location of the vehicle and facilitates remote monitoring of the analysis from the detection probe. The GPS signals the remote computer to temperature spikes and enables a text messages to be sent to a remote site.

Advantageously, the refrigeration vehicle includes a battery powered heating system, which is ideally incorporated into the refrigeration area.

Preferably, the refrigeration area is enclosed with a layer or layers of insulation material.

Conveniently, the insulation is readily removable from the refrigeration area.

Preferably, the refrigeration vehicle includes heavy duty insulating barrier strips at the entrance to the refrigeration area of the vehicle. Ideally, the refrigeration units are operable within the preferred range of 2°C to 8°C.

Preferably, the refrigeration vehicle includes a separate ambient section, which includes a heater unit and a refrigeration unit to maintain products at ambient temperatures that is, for example, between 18°C to 25°C.

Conveniently, the method of the invention includes a separate freezer section to maintain products between, for example, -24°C to -30°C.

An apparatus operating in accordance with a method for temperature controlled delivery of products, the apparatus comprising means for storing products at temperatures in the desired range, means for electronically importing details of stored products into a stock file on a computer, means for accepting orders for stored products from an end-user, means for electronically importing details of the order into an order file on the computer, means for relating order details in the order file to stored product information in the stock file on the computer, means for generating a delivery order notice on the computer, means for issuing the stored product with the delivery order notice from the storage means, means for transporting the issued product to the end-user, the transporting means having a mobile communication system, means for installing the details from the delivery order notice into the communication system and means for updating the stock file and/or the order file on the computer from the mobile communication file once the issued product has been delivered to the end-user.

Preferably, the apparatus of the present invention also comprises the refrigeration vehicle including the features set out above.

Conveniently the method includes the step of providing means for monitoring and rotating products between end-users. Optionally the central computer identifies products that are coming to the end of their lifetime, that is products that are about to reach their expiry date. Conveniently the central computer can check end-user records to ascertain whether or not the product has been used. If the product has not been used the product can be moved to an alternative end-user location for use before the expiration of the product. Optionally, use of products by end-users is constantly monitored thereby enabling the computer to determine the quantity and rate at which a particular product is used by each end-user, thereby determining low-use and high-use end-users. Conveniently products can be rotated between low-use and high-use end-users on an on-going basis.

Optionally, the method includes the step of performing real time identification of patient treatment history to allow rapid and accurate ID of all patients who receive at risk product.

Conveniently, the method further includes a means to provide patient treatment analysis regarding product treatment options and cost projections of on-going management using a chosen product option.

The invention will now hereinafter be more particularly described with reference to the accompanying drawings, which illustrate by way of example only, the structure and operation of an embodiment of the temperature controlled delivery system in accordance with the invention.

In the drawings: - Figure 1 is a schematic flow chart showing the elements of the temperature controlled central distribution, tracking and control system of the present invention;

Figure 2 is a flow chart indicating the information flow between the elements of the temperature controlled central distribution, track and control system;

Figure 3 is a flow chart illustrating the components of the transfer part of the temperature central distribution, track and control system;

Figure 4 is a flow chart illustrating the components of the transfer and receipt part of the temperature controlled central distribution, track and control system; Figures 5 and 6 are flow charts of the in-hospital distribution, tracking and control system;

Figure 7 is a flow chart of the steps involved in generating a stock re-order report;

Figure 8 is a flow chart of the steps involved in generating a stock replenishment order;

Figure 9 is a flow chart of the steps involved in generating stock receipts;

Figure 10 is a flow chart of the steps involved in generating the standing (Call Off) orders patient prescription (GSRN);

Figure 11 is a flow chart of the steps involved in generating delivery orders;

Figure 12 is a flow chart of the steps involved in contacting the patient/hospital;

Figure 13 is a flow chart of the steps involved in generating patients orders report;

Figure 14 is a flow chart of the steps involved in product allocation;

Figure 15 is a flow chart of the steps involved in picking the order;

Figure 16 is a flow chart of the steps involved in packing the order;

Figure 17 is a flow chart of the steps involved in delivery van loading;

Figure 18 is a flow chart of the steps involved in confirming the delivery;

Figure 19 is a schematic diagram indicating the nature of the steps e.g. decision making in each of the flow charts shown in Figures 1 - 18; Figure 20 is a side view of a refrigerated vehicle;

Figure 21 is an end view of a refrigerated vehicle with the rear doors of the vehicle and the door of the refrigerator in an open position;

Figure 22 is a side cross-sectional view of the vehicle.

The elements of the central distribution, tracking and control system of the invention will now be described with particular reference to Figure 1 of the accompanying drawings.

Systems Outline:

The following description details the elements of the System Flow for the Central Distribution, Tracking and Control System (CDTCS).

Master Record Files Patient Records Including: • Patient Master GSRN (PMGSRN). • GSRN (Global Service Relationship Number). • GLN (Global Location Number): A main GLN is included as well as one additional alternative GLN per patient. • Route Code: each patient is associated with a Particular Delivery Route/Journey. • Treatment Centre (Hospital) Code: This code designates the Treatment Centre (Hospital) normally attended by a particular patient. (GLN Code). • Prescriber Code: A code is designated for each clinician and the prescribed code on the patient records identifies the Clinician normally attended. (GLN Code). • Indicative Usage (Shelf Life): Indicates the normal expiration (use by) date. Product Records Including: • GTIN (Global Trade Item Number). • A method of FIFO (First In First Out) stock control is used based on the Batch Number/Expiry Date. Product is allocated by stock Batch/Expiry date. Based on the indicated usage of the patient, the system will provide the patient with the optimum product shelf life.

Cold Store Warehouse/Locations Stock is maintained in the Cold Store Warehouse.

The Warehouse has distinct Location areas. These are for example: • Goods Inward • Cold Store (Main Warehouse Area) • Goods Outward • Pending • Quarantine

There is a Global Location Number (GLN) for each location.

Each Hospital is treated as a location, and there may be sub-locations in each Hospital. There is a GLN for each location and sub-location. Barcode Labels are used in each location for the GLN.

Each Patient has at least one GLN. Barcode Swipe Cards are used in the location. Patient's home fridges are stock locations.

Barcodes and Data Messaging

The Barcodes and Data Messaging requirements have been developed to EAN Standards for Global Identification using EAN Symbology Standards and Data Messaging to EAN Standards. Barcodes

The system uses the EAN.UCC System

Data Messaging and Transfer Methods CDTCS facilitates the use of the Messaging Carrier System incorporating Encryption to AS2 or similar. Messages received are translated and mapped to the CDTCS system. CDTCS maps and translates outgoing messages for onward transmission.

The steps of the method of the invention are now described hereinbelow with particular reference to Figures 2 to 4.

Patient records 10 and approved product information 11 is sent electronically from the Central Issuing Authority to the central computer 20 at steps 101 and 102 respectively. The product information 11 is stored in a stock file and details new products and possible substitute products together with the Global Trade Item Number (GTIN) of both the product and the substitute product. Any other appropriate information is also included. The product is delivered to the storage area 12 from either the Central Issuing Authority or the pharmaceutical companies. When the delivery is accepted at the storage area, the details of the delivery are electronically input by scanning the manufacturer's barcode of the product. All of the required information will be on the manufacturer's barcode. Once each barcode is scanned, the information is relayed electronically to the stock file on the central computer 20 at step 103. Any barcode information not included can be entered manually onto the central computer 20. The stock file is updated using the Global Trade Item Number (GTIN) as an identification number and the quantity, batch and expiration information is added to the relevant product information. The central computer 20 automatically allocates a serial number for each vial of product thereby creating a unique vial box serial barcode label. The vial box serial barcode label is put onto the product, scanned in the storage area, thus becoming available for allocation.

The storage area 12 is divided into two areas, a processing area and a storage refrigerator. The product is initially accepted into the processing area, where scanning occurs. In the processing area, the product is checked for quantity and quality, including a check of the temperature of the product. After checking, if the product is found to be at a temperature outside within the requisite temperature range i.e. outside the range, 2°C to 8°C, the product is rejected and placed in a quarantine area. Accepted product is transferred into the storage refrigerator. The storage area 12 operates with four refrigerator units, which operate alternatively as pairs with the second pair providing a backup in the event of failure of the first pair. The electricity supply to the storage area 12 is backed up by a generator which will start immediately if the electricity supply from the national grid fails.

The temperature of the storage area 12 is maintained between 4°C and 6°C and is monitored constantly to ensure that the temperature remains within the range 2°C - 8°C.

Monitoring equipment is used for both pairs of storage refrigerators, temperature probes are positioned on the two storage refrigerators between the processing area and the storage refrigerators. These probes are supported by two probes located outside the storage area

12 for measuring ambient temperature and also two probes located outside the building also for measuring ambient temperature. There are also connections to the power generator to indicate if the power has failed. As a final precautionary measure there is also a temperature probe that is packaged as a product and is placed in a product container and placed in the storage refrigerator thereby mimicking the conditions in which an actual product is stored. The alarm system is set to activate in the case of temperatures reaching either 3°C and 7°C. This allows time for reaction before the lower and upper temperature limits of 2°C and 8°C respectively are reached.

A computerised control unit is connected to the monitoring equipment and the generator. The control unit has a dial-out unit with a series of telephone numbers, which can be called in the event of alarm activation and/or electricity supply failure. The control unit also enables the refrigeration engineers to access the system so that real-time external monitoring can take place. All temperature data is recorded to allow a continuous audit of the system.

Patient prescriptions 14 are generated by the prescribing physician and are sent electronically to the pharmacist 13 at step 105. The pharmacist 13 sends the prescription or order to the central computer 20 at step 106. Alternatively, the prescription may be forwarded directly from the prescribing physician to the central computer 20 at step 109. The prescription information is correlated with the information held in the stock file on the central computer 20 and the relevant product is assigned to that prescription at step 21.

A picking list 22 relating the prescription or order to the product containing all the relevant product information is generated by the central computer 20 and is forwarded electronically to the storage area 12 at step 107. At the storage area 12, the product is selected at step 23 and verified by the barcode. A dispensing label 24 is then generated for each of the GTINs within a package. A Serial Shipping Container Code (SSCC) barcode label 24 is generated and placed on the outer box reflecting the product contained within. The SSCC barcode label contains the Global Trade Item Number (GTIN), Patient Master Global Service Relationship Number (PMGSRN), GLN and other relevant data.

A delivery order notice 25 is generated in conjunction with the dispensing label and the SSCC barcode label 24 and is dispatched with the product. The product is issued from the storage area 12 into the refrigerated van at step 26. The SSCC barcode label 24 is scanned electronically as the product leaves the storage area 12. Each refrigerated van is assigned a Global Location Number (GLN). The Global Location Number (GLN), together with the date and time of each dispatchment of product is input into the General Packet Radio Service (GPRS) system of the van, this is then communicated to the central computer 20 at step 27. The location of the refrigerated van can be monitored at all times using the Global Positioning System (GPS) system.

Once the records have been updated at step 27, delivery of the product to the end user is effected at step 28. This delivery might be at the hospital or pharmacy 14a or directly to the patient 14b. On arrival at the delivery point, the driver of the refrigerated van scans the SSCC barcode label 24 and the delivery date and time are also entered either manually or automatically. This data is transmitted to the central computer 20 from the GRPS system 30.

In the case of a delivery to the pharmacy or hospital 14a, a further barcode 15a is scanned which identifies the hospital or pharmacy 14a as the point of delivery. Once the delivery is made to the hospital or pharmacy 14a, responsibility for the delivery is transferred to either the hospital or pharmacy, respectively. However, in the case of a delivery directly to a patient 14b, the delivery is made to an appropriate designated point. This is very often a refrigerated unit with suitable identification means i.e. barcode and/or security tag 15b. Delivery is only completed in this case when the driver scans the appropriate identification means, namely, either barcode 15a or security tag 15b. Once delivery is completed at step 29, the central computer is again updated by the GRPS system 30.

There are a number of different options when delivering directly to a patient or a hospital/pharmacy. Swipe cards are provided for each Patient location (GLN) and each Hospital/Pharmacy location (GLN).

In the case of directing delivery to the patient's home (Patient direct), the delivery is to the appropriate designated point, which has the patient's GLN Barcode swipe card available for validation. The driver scans the GLN Card, which is validated against the data in the driver's Hand Held device. The SSCC and GLN labels on the Tote boxes are scanned, confirmed and delivery complete. The confirmed product delivery is updated to the Hand Held device including time and date stamp. The Patient signs electronically for the delivery. A signature is obtained for all deliveries irrespective of the delivery point.

Patient Mobile: This is a swipe card which the Patient carries with them or leaves with, for example, a neighbour or office reception, for scanning on delivery. The swipe card is made available to confirm delivery and a signature is obtained.

In the event that the delivery instructions are changed by agreement prior to delivery, then the new destination is not a designated GLN on the Patient's Master Record, facility is provided within the method, apparatus and system of the invention to complete the delivery. This is considered an "Unregistered GLN" and the address is manually input to the hand held. A report of such deliveries is provided. The completed delivery information is transmitted via GPRS to the communications Server in CDTCS.

Multiple deliveries to one location are possible. This means that the same delivery to GLN could be used for more than one Patient.

Delivery data is downloaded from the drivers' Hand Held device on return to the CDTCS Warehouse. The confirmed deliveries are updated to CDTCS, which confirms the stock movement and records the delivery time and date. In the case of those deliveries not completed an exception status is recorded.

Delivery to the Hospital is to a designated refrigerated area and is made in similar fashion to that for delivery to the Patient. There is an in house network made available in the Hospital. Each location has a GLN. The GLN Barcode is firmly attached or fixed.

The In Hospital Locations include; Blood Transfusion Laboratory Fridge (Server), Wards, Quarantine, ICU and Casualty. The hospital server application stores Patient details including: Patient Master GSRN, GSRN, Name and Address and Date of Birth.

The Hospital system has a facility to capture movements. Issues, returns etc. are scanned and recorded. A menu system is provided to cover all types of potential movements. A transaction code is provided to identify each type of movement. When a Patient presents at the Hospital, their details are selected from the file. This includes Patient Master GSRN and Name and Address. Date of Birth can be used in the case of Patients with the same name.

Using a keyboard wedge scanner, the Vial Boxes selected for the Patients treatment are scanned and the details stored on the Hospital Server. The transactions are captured on the central distribution, tracking and control system (CDTCS) of the present invention. The Patient details file is updated on a regular basis from CDTCS The central computer 20 then electronically advises the hospital or pharmacy 14a at step 108 that delivery has been completed. The central computer also advises the Central Authority 20a and/or other relevant authorities 14d that the delivery has taken place. This in effect maintains quality control of the central distribution, tracking and control system.

A detailed description of particular aspects of the system of the invention will be described hereinbelow.

Stock Replenishment - Ordering and Receiving Product: With particular reference to Figures 7 and 8, the stock re-order steps of the system will now be described.

Stock Re-ordering

Each product has a re-order stock level. A report highlights items at the re-order level. Initially, a Suggested Purchase Order is raised for items when they reach their Reorder Level. The Responsible Person (RP) reviews this and a Stock Replenishment Order is issued.

Stock Receipts With particular reference to Figure 9, the steps involved in stock receipt will now be described.

Product delivery is accepted into the Goods-In area in the Cold Store Warehouse. Each delivery is processed on a batch-by-batch basis. The appropriate Quality Control check-in procedure is carried out. This quality control check-in procedure includes validating that the product and quantity received are consistent with the supplier delivery docket.

Inputs into the CDTCS Supplier Reference (GLN) Warehouse Number (GLN) Stock Replenishment Order Number GTIN Code (Scanned) Batch Number Expiry Date Quantity of Vial Boxes Received

The Central Distribution, Tracking and Control System (CDTCS) of the invention validates that the correct Stock Replenishment Order is being processed. The required stock Global Trade Item Number (GTIN) is selected and the batch processed by entering the Batch Number, Expiry date and number of Vial Boxes received.

CDTCS automatically allocates the next available Serial Numbers in sequence to the Vial Boxes in the batch. CDTCS allocates consecutive Serial Numbers within Batch. These are stored and the system allows for separate receipt of deliveries of the same batch number.

The Central Distribution, Tracking and Control System (CDTCS) prints a Barcode Label, called the Vial Box Serial Number Label for each Vial Box in the batch. This label contains:

• GTIN Product Code • Batch Number • Expiry Date • Unique Serial Number (Serial Number within Batch)

A label is attached to each individual Vial Box in the batch.

In the event of a shortage or an over delivery, CDCTS provides the facility to "cancel" specified labels (with a reason code) or to produce additional labels.

At this point, the goods receipt for the batch is complete. The products are transferred directly into the Cold Store Main Warehouse area. The physical transferral of the products is accompanied by scanning each Vial Box in the batch out of the "Goods-In" and into the "Cold Store zone" of the Warehouse area. The products are placed "in stock" on CDTCS and therefore available for allocation. Supply of Product:

With particular reference to Figure 10, the steps involved in supplying product (according to orders prescribed) will now be described.

Patient Prescriptions (Orders) GSRN

A "Standing Orders" file is created for Patient Prescriptions and maintained in CDTCS. This has the Patients "standing" or usual requirement. Each Patient Standing Order references a PMGSRN and GSRN. There are two types of change to a standing order. Change Orders (a new prescription for a Patient), which is a permanent change, and Specific Order Requests (additional or special requirements for a Patient), which is a temporary or one off change.

Each Standing Order has a maximum deliverable quantity per prescription. CDTCS provides an alert for those Patients approaching this level within the time scale covered. Some form of emergency requirement or similar event could cause this, for example. CDTCS will not allow delivery of quantities beyond this level without the intervention of the responsible person (RP).

There may be more than one product type on a Standing Order. The original Standing Order may be amended as a result of a Change Order. This may only affect one item on the Standing Order. CDTCS will maintain reference to these changes.

There are two ways to maintain a Standing Order. There is the facility to receive an electronic message from the Prescribing Clinician via EAN Messaging system and a facility to manually input a prescription direct.

The standing orders file allows facility for the input of dispensing details for incorporation onto a dispensing label. There is one dispensing label for each product type on an order. Change Orders and Specific Order Requests are input to the Standing Orders file on CDTCS in similar fashion to the Standing Order.

Emergency Orders Emergency Orders are given priority within the CDTCS Distribution System. Emergency Orders are processed as a route and follow the system flow through to delivery as a single route, single (or multiple if appropriate) order delivery. The distribution process is completed for Emergency Orders, but they have priority over the normal standing order deliveries.

Order Production, Picking and Dispensing

Create Delivery Orders Referring now particularly to Figure 11, the steps involved in generating delivery orders will be described.

A delivery order is produced for a Patient based on their Standing Order. Any changes either temporary or permanent are reflected on this Delivery order. Delivery Orders are produced for all Patients allocated to a particular Journey.

Patient Contact

Referring now to Figure 12, the steps involved in contacting the patient will be described.

The responsible person (RP) will amend/delete/confirm the delivery orders as appropriate. All Patients in a particular journey are contacted and their requirement is checked against the suggested delivery order. Any changes, along with confirming the patients' required GLN, are made to the order. The responsible person (RP) can alter the route sequence or can change the GLN delivery point manually for a specific delivery.

The confirmed orders are the basis for instigating the delivery process.

Suggested Patient Orders Report Referring now to Figure 13, the steps involved in producing a suggested patient orders report will be described. CDTCS produces a suggested Patient Orders report based on the Route to be serviced. This report lists the patient, PMGSRN, GSRN and any changes made to the standing order.

The Responsible Person (RP) can review the suggested orders report.

Product Allocation

Referring now to Figure 14, the steps involved in product allocation will be described.

CDTCS system allocates products to orders on a route Journey. Orders are processed in Patient/Route order. Products are allocated by Batch and Expiry date. Certain Patients have an indicative Shelf Life requirement. The system will provide these Patients with products having a longer shelf life. When this is not possible an exception report will be produced.

The responsible person (RP) is allowed to manually allocate product to an order in specific circumstances.

Order Picking List

Referring now to Figure 15, the steps involved in picking the order will be described.

Picking lists are printed in the Warehouse. Each delivery order has a picking list.

The picking list contains the order details including:

Patient Master GSRN Warehouse Number Route Number Delivery Order Number Delivery Date GSRN Name Address • GLN • GLN Address • Order Number

Per Batch/Product: GTIN Product Identity Number Product Description Batch Number Expiry Date Quantity

The data for the order is sent to the Hand Held device.

Order Picking

The order is picked and placed in the appropriate container (basket) taking detail from the printed picking list.

The Delivery Number and Warehouse GLN are scanned into the Hand Held Terminal for validation and the product Vial Boxes are scanned individually. In this way the individual Serial Numbers for each Vial Box are input to the system.

The Hand Held terminal will contain the full stock list of Vial Boxes available for selection. As each Vial Box is selected CDTCS confirms/validates that it is available and is appropriate for the delivery order.

The scanned data is compared with the order data and confirmed on the Hand Held. This ensures that the products picked match the products ordered.

Any discrepancy is dealt with at this time. If there is a discrepancy, the whole order can be rejected and the process recommenced for that particular order.

The order is confirmed as Picked and awaiting Packing. Order Packing

Referring now to Figure 16, the steps involved in packing the order will be described. The picked order is now validated and packed by scanning the individual Vial Boxes, comparing against the order, viewing the product, confirming the Patient details and placing them in a Tote box.

The quantity of Tote Box Labels needed is calculated and CDTCS will print an individual SSCC (Serial Shipping Container Code) Barcode label for each Tote box to be used for the delivery. These are fixed to the Tote boxes. The SSCC number is created by CDTCS on a sequential basis. This label also shows the PMGSRN and GLN in Barcode format and Patient Name and Address in readable form.

Using the Hand-Held the SSCC is scanned, as also are the Vial Boxes as they are placed into the Tote box. When a box is full this is indicated to the system and the next box is packed in similar fashion. CDTCS now has a record of each SSCC and the Vial Boxes associated with it.

On completion of the delivery order CDTCS provides the following: ^■ Printed Delivery Docket including Printed Barcode GLN, printed Barcode PMGSRN, and printed Barcode Delivery Order Number printed SSCC Number.

■ Dispensing Label (one for each product on the order).

The order is confirmed as Picked and awaiting Dispensing.

Dispensing

The responsible person (RP), who also attaches the dispensing labels, can now dispense the order.

The Tote box is closed and sealed and placed in Goods-Out awaiting delivery. Delivery

Referring now to Figure 17 and Figure 18, the steps involved in delivery van loading and confirming the delivery will be described.

Route Summary Sheet

A Summary Sheet is printed in Route Order. This includes the Tote Box SSCC numbers per Patient.

Cold Chain Vehicle The Tote Boxes are issued from the Goods-Out in the Warehouse and placed into the Cold- Chain Refrigerated Vehicle.

The delivery data is downloaded from CDTCS to the Hand Held device for the vehicle. This includes the GLN for Patient delivery and SSCC. This data is in route order.

The driver confirms that the correct Tote Boxes have been loaded by means of scanning and comparison of the SSCC Barcodes.

Each Refrigerated Vehicle is assigned a Global Location No (GLN).

Delivery Points

There are a number of optional points of delivery:

Patient Home GLN; Alternative Patient GLN; Hospital GLN; or Pharmacy GLN.

Delivery is validated by scan and comparison of GLN codes. Patient Delivery

There are 4 possible delivery situations: A. Delivery to Patient Home (GLN 1) B. "Mobile" (GLN 2) (Patient Work or other address) C. Un-Registered GLN as outlined below D. Sign off by Delivery Person (GLN 1).

Swipe cards are provided for each Patient location (GLN) and each Hospital location (GLN). These are used to validate deliveries to the Patient.

A. In the case of directing delivery to the patient's home (Patient direct), the delivery is to the appropriate designated point, which has the patient's GLN Barcode swipe card available for validation. The driver scans the GLN Card, which is validated against the data in the driver's Hand Held device.

The SSCC and GLN labels on the Tote boxes are scanned, confirmed and delivery complete.

The confirmed product delivery is updated to the Hand Held device including time and date stamp.

The Patient signs electronically for the delivery. A signature is obtained for all deliveries irrespective of the delivery point.

B. Patient Mobile: This is a swipe card which the Patient carries with them or leaves with, for example, a neighbour or office reception, for scanning on delivery. The swipe card is made available to confirm delivery and a signature is obtained. C. In the event that the delivery instructions are changed by agreement prior to delivery, then the new destination is not a designated GLN on the Patient's Master Record, facility is provided within the method, apparatus and system of the invention to complete the delivery. This is considered an "Unregistered GLN" and the address is manually input to the hand held. A report of such deliveries is provided.

D. Sign-off by Delivery Person: To be used if the Patient GLN Barcode is not available for whatever reason. This facility allows the driver to scan the GLN number from the delivery docket. A transaction code is allocated to allow the driver to indicate that this is what has happened.

In the event that a delivery fails or, for a legitimate reason, the Patient requests a part delivery only, the goods are returned to the Pending Area (GLN) and a decision is then made on these items. If the delivery is cancelled, the goods are returned to the Cold Store. The returned items are entered into Pending on CDTCS and are further processed when a decision is taken as to the appropriate course of action.

The completed delivery information is transmitted via GPRS to the communications Server in CDTCS.

Multiple deliveries to one location are possible. This means that the same deliver to GLN could be used for more than one Patient.

Delivery data is downloaded from the drivers Hand Held device on return to the CDTCS Warehouse. The confirmed deliveries are updated to CDTCS, which confirms the stock movement and records the delivery time and date. In the case of those deliveries not completed an exception status is recorded.

A flash card is used for the Hand Held device as an additional security measure. Patient Usage

Each Patient is provided with a Hand Held device, either Smart Phone or PDA, for use in the Home environment. This is either a Java Enabled Camera Phone, with or without Bar Code Reader or XDA II Smartphone with external SDIO Bar Code scanner. Area coverage is a dictator of the type of device. The Patient scans Vial Boxes out of the fridge and inputs a transaction type code to indicate the reason for the movement. The data captured is transmitted to CDTCS and captured on the CDTCS communications Server. The transaction data is updated to the Patient Stock file on CDTCS.

Hospital/Pharmacy Delivery

Referring now to Figures 5 and 6, the in-hospital CDTCS will now be described.

Delivery to the Hospital is to the designated Blood Transfusion (BT) Laboratory refrigerated area and is made in similar fashion to that for delivery to the Patient.

Orders for the Hospital are input to CDTCS in similar fashion to the Patients order input other than that these are stock orders for the Hospital and as such are delivered "into stock" in the Hospital location.

In addition, there is an in house network made available in the Hospital. Each location has a GLN. The GLN Barcode is firmly attached or fixed.

The In Hospital Locations include • BT Laboratory Fridge (Server) • Wards • Quarantine • ICU • Casualty

The Server application stores Patient details including: • Patient Master GSRN • GRSN • Name and Address • Date of Birth

The Hospital system has a facility to capture movements. Issues, returns etc. are scanned and recorded.

A menu system is provided to cover all types of potential movements. A transaction code is provided to identify each type of movement.

When a Patient presents at the Hospital, their details are selected from the file. This includes Patient Master GSRN and Name and Address. Date of Birth can be used in the case of Patients with the same name.

Using a keyboard wedge scanner, the Vial Boxes selected for the Patients treatment are scanned and the details stored on the Hospital Server.

The transactions are captured on the central distribution, tracking and control system (CDTCS) of the present invention.

The Patient details file is updated on a regular basis from CDTCS.

Returns from Patient/Hospital Product can be handed back to the driver from either Patients or Hospitals.

These items are brought back by the driver and placed in Quarantine. A decision is taken as to the course of action to follow for each return.

CDTCS provides the facility to log the return against the initial recipient and to indicate the action taken with the returned product. Stock Control Product Stock Rotation

The CDTCS system maintains a FIFO/Expiry Date basis of stock so that it is always delivering in the correct manner from the warehouse. CDTCS provides a Report detailing the list of products approaching Expiry date (based on date range entry, re-order level and minimum stock level) in respect of each Patient, Warehouse and the Hospital locations.

The Report is provided to the Hospital for action.

Stock can be transferred between Depots and Locations. This is carried out by scanning the product Vial Box out of the current location and into the location to which it is to be moved. There is a facility for a transaction code to describe the movement. The transaction types include Wastage, Returns etc. There is also a facility to handle lost or unaccounted for Vial Boxes.

Quarantine Stock

An area is allocated in the Cold Store Warehouse and Hospital for Quarantined Stock.

This is treated as a stock location and has a GLN.

This area holds products returned by recall, instruction etc.

It also holds products for other reasons such as damage, return by Hospital or Patient etc.

The system provides a manual entry facility to record final movement of the product once that decision has been made.

Pending Stock

An area is allocated in the Cold Store Warehouse for Pending Stock.

This is treated as a stock location and has a GLN.

This area is used to hold failed deliveries pending action. Product Stock Check

CDTCS maintains stock items by Product, Batch and Serial Number for the Cold Store Warehouse locations and the Hospital BT and other Patient locations.

The system provides details of its stock holdings in respect of a specific location for Stock Check purposes.

In Hospital Patients

Product issued to in-hospital Patients is processed through the In Hospital stock system. The Patient Master GSRN is captured via swipe or entry and is stored along with the transaction code, reason code and Product Vial Box details. The data is forwarded to CDTCS.

Provision is provided to handle visitors from other countries etc. who are not members of the main database.

Updates

The Issuing Authority is notified by electronic means following the completion of the delivery cycle. This report provides all delivery and Patient details for the route and, in the case of the Hospital, the stock delivery details.

Replenishment Stock Orders

CDTCS provides a suggested replenishment order report based on usage and minimum stock level. This is reviewed by the RP and a Replenishment Stock Order issued for each stock holding.

The Replenishment Order Number is used to validate stock receipts.

Daily Delivery Report At the end of each day a report is prepared and sent to the Issuing Authority detailing the Hospital deliveries carried out for that day. The report in respect of the Cold Store Warehouse covers all Patient and Hospital deliveries managed by the Cold Store.

Access Between Clinical/PAS Systems and CDTCS System User Access from Clinical/PAS Systems to CDTCS Stock System

An "icon" is provided to allow access to the CDTCS stock system from the Clinical/PAS system desktop. This is provided to: a) Allow Stock level enquiry. This is limited to certain operations subject to Password validation. b) Request and generate certain reports remotely. This is most particularly a Recall Report. The user is allowed input parameters such as GTIN, Batch Number and Expiry Date whereupon the system will generate the report. The report lay out is designed and available to the users. The ability to generate reports is limited to certain reports and is subject to Password validation.

User Access Systems Standards and QC.

Access is available in similar fashion to that outlined above.

This is read only and a number of Stock Reports are pre designed to allow input of variable parameters. The Reports are produced in the Hospital to facilitate the daily Quality Control routines.

The reports include:

• Daily Stock Reconciliation per In Hospital location. • Report detailing In-Hospital Quarantine Items. Daily Stock Check. Connectivity with Clinical/PAS System from CDTCS.

The main areas of connectivity are as follows:

Clinical/PAS system provides CDTCS in agreed format via encrypted message: 1. Data incorporating New Patients (PMGSRN), Name and Address, GLN's and the other static details. 2. Data in respect of changed static data circumstance for existing Patients. 3. New Standing Orders, Change Orders and Emergency Orders (including GSRN).

CDTCS provides Clinical/PAS system in agreed format via encrypted message: 1. Data reporting the daily deliveries. 2. Reports including Recall.

Messages have acknowledgements of receipt.

Reports

The system records product deliveries per Patient and is therefore able to report delivery patterns.

In the case of the Hospital, Re-order levels are implemented and warnings issued if this limit is being approached.

In addition reports provided include:

Standard Stock Reports. Stock Valuation Stock Levels Stock Re-Order Journey Reports Patient Reports Rotating Stock Report Product Utilisation Report Customised Reports

• Hospital and/or Patient Reports - No of Deliveries - Batch Number Usage - By Product/Serial Number - By Patient/Hospital

• Product Reports. - By Batch/Serial Number - By Month - By Patient/Hospital - Products Returned to Supplier

• Batch Report - By Expiry Date - By Patient/Hospital - By Serial Number

• Region / County Analysis • Product Report • Deliveries Report • Batch Recall Report

CDTCS provides Product Cost Prices at Vial Box level.

The cost price is used to provide valuations as an Average Cost on reports taking the quantity delivered and the cost price per Vial Box.

It is possible to provide previous year comparative data when the system has been implemented over a sufficient period to gather this data. This includes year to date and last year to date comparisons. Stock reports are provided by stock location. It is also possible to provide special reports, which are based on the available data in the CDTCS database.

Data for Reports is also provided from CDTCS to the Clinical PAS systems to allow them to incorporate these details into the Clinical Reports they will be providing from their system.

Recall

The system provides a recall report to two levels.

A. An overall Report showing: • Per Product • Batch Number • Location • Quantity

B. Where appropriate to a detail level including Serial Number.

A mail merge facility is provided so that a Notice may be sent as well via email, post or other appropriate methods.

Audit Trail

There is a full verifiable Audit Trail provided to cover the steps in the distribution system sequence. This provides the facility to carry out a visual check at key points in the distribution process. The Audit Trail includes:

• Stock Replenishment Orders • Suggested Orders • Delivery Orders • Picking Lists • Delivery Dockets • Route Summary Sheets Each document has facility for authorised signatures.

Locations

CDTCS caters for Multiple Treatment Centres (Hospitals), where the data captured is collated and reported to the Issuing Authority.

Refrigeration Vehicle

Referring to Figures 20, 21 and 22, the refrigeration vehicle 100 comprises two refrigerating units 120 (Main Unit) and 140 (Back-up Unit) mounted on the roof of the vehicle. Each refrigeration unit comprises an evaporator 120a and 140a, a condenser 120b and 140c. The main refrigerating unit 120 is connected and powered by the engine 100. The back-up refrigerating unit 140 is powered by the auxiliary battery 200 and can also be powered from a mains electricity supply 600. The auxiliary battery 200 is linked to the engine battery 10 and is recharged via an alternator 40 when the vehicle 100 is in motion.

The back-up refrigeration unit 140 is switched on by the driver when the engine is switched off. Alternatively the back up refrigeration unit 140 can be switched on while the main refrigeration unit 120 is in operation. Generally, this will only occur when the external ambient temperature is very high and auxiliary cooling is required.

An isolation relay switch 500 is activated when the vehicle 100 is not in use to prevent power being drained from the main battery unit of the engine 100.

Audio and visual alarms are built into the dashboard 200 of the vehicle. A global positioning system 230 is built into the vehicle 100, the aerial 220 of the GPS being positioned on the roof of the vehicle 100. The GPS 230 is linked to a temperature monitoring unit 210 which enables the driver of the vehicle to monitor the temperature at all times. The vehicle is tracked by a remote computer using the GPS 230 and Global Positioning System tracking technology which is linked to a data communication unit such as a GSM modem. Furthermore, the temperature data generated during a vehicles journey can be downloaded through a Data Carrier Unit (DCU) device and loaded to a remote computer for analysis and storage. Both systems allow interrogation of the vehicle positioning and temperature data in real-time or historic or a combination of both. This is performed on the GPS 230 by means of a GSM communication from the remote computer to the host unit in the vehicle. Any untoward event relating to temperature is signalled through the data communication unit back to base. The remote computer is then capable of SMS messaging to alert an on-call staff member such as the driver of the vehicle or a technical engineer.

The refrigeration area 420 has a number of probes 110, 150, 160 and 170 positioned within it. There are three air probes, 150, 160 and 170 respectively and one product probe 110. The product probe 110 is packaged as if a real product and placed in a product container within the refrigeration area 420, thereby mimicking a real product. Each of the probes 110, 150, 160 and 170 are connected to the monitoring unit 230 within the cab of the vehicle 100.

The door 400 of the refrigeration unit is also connected to the monitoring unit 210, thus providing an indication every time the door 400 is opened and closed via switch 180.

As can be seen in Figure 21, when the rear doors 300 of the vehicle are opened, another door 400 of the refrigeration area 420 has to be opened to gain access to the area. The fridge door 400 is purpose built for extra insulation and extra insulation 440, approximately, double the normal, is provided for the refrigeration area 420.

Example of Validation Testing of the Refrigeration Vehicle

Performance & Operational Qualification

Example Protocol

Currently, the main refrigeration unit on the vehicle is a Carrier Transicold Xarios 200 unit 120, supported by a Carrier Transicold Basic 700 back up refrigeration unit 140. Any suitable refrigeration unit known to a person skilled in the art can be used. The equipment was designed to ensure operating temperatures can be maintained over pre-set ranges at all times e.g. 2°-8°C. The monitoring unit was a Tanscan 2 temperature recorder with four temperature probes (three air 150, 160 and 170 and one product 110) in the refrigeration area.

The refrigeration vehicle 100 is tested under normal operating conditions. Each test taking at least 4 hours, monitoring every lOmins. There are eight test locations in the refrigeration area 420. The position of the test probes are identified on Temperature Probe Location Forms. Each location is tested for 4 hours with the fridge empty (one test) and 4 hours with the fridge loaded (second test). Two operational 6 hour tests are then carried out, thereby testing the vehicle 100 under full operational conditions. The hot and cold spots are then analysed and the final position of the probes for general use decided. Alarm tests are also carried out at both high and low set points.

Example Acceptance Criteria

The fridges should show operational temperatures of within the set range appropriate to the product requirements at all times. In this example, the temperature range is 2°-8°C.

Any test that gives results outside the required limits is analysed and the reason for the deviation found. This is then corrected before further testing commences.

Example Report

A Cold Chain Service is offered to Health Boards, Hospitals and Pharmaceutical companies. The service involves refrigerated storage of pharmaceutical products at an appropriate warehouse, and refrigerated nationwide transport to deliver direct to health authorities and/or hospitals.

All refrigerators used and the transport systems are subject to validation. Each refrigeration vehicle and transport procedures will are tested initially in both winter and summer conditions and then on an annual basis thereafter. Daily analysis occurs during normal operation of the vehicle 100. Aims of Validation

Most regulatory authorities require that validation and requalification processes should establish and provide documentary evidence as out lined below: • The premises, the facilities, the equipment and the processes have been designed in accordance with the requirements of current G.D.P. (Good Distribution Practice.) • The equipment has been installed in compliance with their design specifications.

The aim of this validation process will be to show that the facilities and equipment operate in accordance with their design specifications. This Process Qualification (P.Q) will show that the equipment and processes operate to a consistent and reliable standard, maintaining the integrity of the product at all times.

Any aspect of, including significant changes to, the vehicle, the equipment or the processes, which may affect the quality of the product, directly or indirectly, should be qualified and validated.

Requalification will occur annually or at another time where the changes outlined above require it. Appropriate documentary evidence will be carried out with each validation or requalification. Initial validation testing will be repeated during the winter to show testing through the two extremes of temperatures. The initial validation work will be carried during the summer.

The vehicle 100 used is a refrigerated vehicle.

It will or course be understood that the present invention is not limited to the specific details herein described which are given by way of example only, and that various alternations and modifications may be made without departing from the scope of the invention as defined in the appended claims.

Claims

CLAIMS:

1. A method of tracking and tracing a product comprising one or more units and providing temperature controlled delivery of the product from a storage area to an end-user and providing the capability of realtime recall of the product to individual unit level at any stage during the steps of the method, the method comprising the steps of: storing products in a storage area at the required range of temperatures; importing details of the stored products to a stock file on a computer; accepting orders for stored products from an end-user; importing details of each order into an order file on the computer; generating a unique serial number for each individual unit within a batch relating order details in the order file to stored product information in the stock file on the computer; generating a delivery order notice which includes product information from stock file on the computer; issuing stored product and the delivery order notice from the storage area; placing issued product and the delivery order notice into a refrigerated vehicle with temperatures at the required range, the refrigerated vehicle having a Global Positioning System; importing information on the delivery order notice electronically into a general packet radio service communication system; delivering issued product from the refrigerated vehicle to an end user; and updating the stock file and/or the order file on the computer from general packet radio service communication system once delivery of issued product has been completed.

2. A method as claimed in Claim 1, further comprising the step of providing a secure means for tracking and tracing products from the storage area to the end-user.

3. A method as claimed in Claim 1 or Claim 2, further comprising the step of recalling products to the storage area at any stage during the steps of the method, should a problem with a particular product be detected.

4. A method as claimed in any one of the preceding claims, further comprising the step of using international standards to uniquely identify each product.

5. A method as claimed in any one of the preceding claims, further comprising the step of using an international standard barcode system to uniquely identify each product.

6. A method as claimed in any one of the preceding claims, further comprising the step of using EAN Barcodes to uniquely identify each product.

7. A method as claimed in any one of the preceding claims, further comprising the step of giving each product a barcode when produced.

8. A method as claimed in any one of the preceding claims, further comprising the step of giving each product a second barcode when storing the product.

9. A method as claimed in Claim 7 or Claim 8, further comprising the step of including a Global Trade Item Number identifying the product name and strength in the barcode.

10. A method as claimed in any one of Claim 7, Claim 8 or Claim 9, further comprising the step of including at least one of the following pieces of additional information, quantity information, serial number, batch information, and expiration information in either barcode.

11. A method as claimed in Claim 10 further comprising the step of scanning the or each barcode of each product, for electronic entry of product information into the stock file.

12. A method as claimed in any one of the preceding claims, further comprising the step of using network and telecommunication systems that facilitate a secure environment for data transmission.

13. A method as claimed in Claim 12, further comprising the step of using a central computer within the network to store the product and order information in stock and order files respectively.

14. A method as claimed in Claim 13, further comprising the step of enabling access to the central computer as required by other computers on the network.

15. A method as claimed in any one of Claims 13 or Claim 14, further comprising the step of storing other pertinent information such as patient record files, possible substitutes for some or all of the products and patient prescriptions on the central computer.

16. A method as claimed in any one of the preceding claims, further comprising the step of using a general packet radio service communication system to update the central computer when making deliveries.

17. A method as claimed in any one of the preceding claims, further comprising the step of: producing patient prescriptions from a doctor or a hospital electronic format; and the pharmacist forwarding the electronic prescription as an order to the temperature controlled system.

18. A method as claimed in any one of the preceding claims, further comprising the step of producing a dispensing label when the product is issued from the storage area.

19. A method as claimed in any one of the preceding claims, further comprising the step of attaching the dispensing label to each individual product.

20. A method as claimed in any one of the preceding claims, further comprising the step of including information such as a Global Relationship Service Number which identifies the relationship between two separate entities in the dispensing label.

21. A method as claimed in any one of the preceding claims, further comprising the step of relocating the delivery location at any stage during the delivery process.

22. A method as claimed in any one of the preceding claims, further comprising the step of updating the stock and/or order files on the central computer once all deliveries have been completed using the GRPS system.

23. A method as claimed in any one of the preceding claims, further comprising the step of electronically advising the appropriate authorities that the delivery cycle has been completed using the central computer.

24. A method as claimed in Claim 17, further comprising the step of delivering the order to a pharmacist from whom the patient can collect it.

25. A method as claimed in Claim 17, further comprising the step of delivering the order directly to the patient.

26. A method as claimed in any one of Claims 1 to 23, including the step of delivering issued product from the refrigerated vehicle to an end user in a hospital; the hospital being provided with a hospital storage area at the required range of temperatures; and the hospital having designated locations, each designated location having an assigned Global Location Number (GLN).

27. A method as claimed in Claim 26 wherein the in-hospital designated locations include: a refrigerated area; wards; product quarantine area; intensive care unit (ICU); and Accident and Emergency (Casualty) Department

28. A method as claimed in Claim 26 or 27 further including the step of storing on the central computer, information on the patient record including the following details: patient Master Global Service Relation Number (GSRN); and name and address of patient and date of birth.

29. A method as claimed in any one of Claims 26 to 28 wherein when a patient presents at the hospital, the appropriate patient record is retrieved from the computer including the patient Master Global Service Relationship Number (GSRN).

30. A method as claimed in Claim 29 including the step of scanning the bar code on the vial box(es) selected for the patient's treatment and storing the details-on the computer.

31. A method as claimed in any one of the preceding claims, further comprising the step of rotating products between one or more end users.

32. A method as claimed in any one of the preceding claims, further comprising the step of advising the appropriate authorities of untoward usage and expiry date matters.

33. A method as claimed in any one of the preceding claims wherein the refrigerated vehicle comprises: (a) a refrigeration area operable within a required temperature range by at least two refrigeration units, a first refrigeration unit operable by the vehicle's power supply and a second refrigeration unit operable by both a battery and mains electrical supply, (b) at least one detection probe for monitoring the temperature of the refrigeration area, (c) a monitoring unit for recording and displaying the temperature data from the detection probe, and (d) an alarm unit is triggerable when the temperature of the refrigeration area reaches a pre-set minimum or maximum temperature on the monitoring unit.

34. A method as claimed in Claim 33, wherein the first refrigeration unit comprises a primary refrigeration unit and the second refrigeration unit comprises an auxiliary refrigeration unit.

35. A method as claimed in Claim 33 or Claim 34, wherein the detection probe comprises a plurality of air-temperature probes and at least one product probe.

36. A refrigeration vehicle as claimed in Claim 35, wherein the product probe comprises a temperature probe packaged as a product and placed in a product container thereby mimicking a real product.

37. A refrigeration vehicle as claimed in any one of Claims 33 to 36, wherein the alarm unit comprises at least one alarm triggerable when the temperature of the refrigeration area reaches the pre-set minimum or maximum temperature within the required operable temperature range. i

38. A method as claimed in Claim 37, wherein the alarm unit is triggerable when the temperature of the refrigeration area reaches within 1°C above the minimum temperature within the required temperature range or 1°C below the maximum temperature within the required temperature range.

39. A method as claimed in Claim 38, wherein the alarm unit comprises a second alarm which is triggerable when the temperature of the refrigeration area reaches the minimum temperature within the required temperature range or the maximum temperature within the required temperature range.

40. A method as claimed in any one of Claims 33 to 39, wherein the Global Positioning System (GPS) facilitates remote monitoring of the location of the refridgeration vehicle and facilitates remote monitoring of the analysis from the detection probe.

41. A method as claimed in Claim 40, wherein the Global Positioning System (GPS) signals the remote computer to temperature spikes and enables a text messages to be sent to a remote site.

42. A method as claimed in any one of Claims 33 to 41, wherein the refrigeration vehicle includes a battery powered heating system.

43. A method as claimed in Claim 42, wherein the battery powered heating system is incorporated into the refrigeration area.

44. A method as claimed in any one of Claims 33 to 43, wherein the refrigeration area is enclosed with a layer or layers of insulation material.

45. A method as claimed in Claim 44, wherein the insulation is readily removable from the refrigeration area.

46. A method as claimed in any one of Claims 33 to 45 including heavy duty insulating barrier strips at the entrance to the refrigeration area of the refrigeration vehicle.

47. A method as claimed in any one of Claims 33 to 46 wherein the refrigeration units are operable within the prefeπed range of 2°C to 8°C.

48. A method as claimed in any one of Claims 33 to 47 wherein the refrigeration vehicle includes a separate ambient section, which includes a heater unit and a refrigeration unit to maintain products at ambient temperatures that is, for example, between 18°C to 25°C.

49. A method as claimed in any one of Claims 33 to 48, including a separate freezer section to maintain products between, for example, -24°C to -30°C.

50. An apparatus operating in accordance with a method for temperature controlled delivery of products, the apparatus comprising means for storing products at temperatures in the desired range, means for electronically importing details of stored products into a stock file on a computer, means for accepting orders for stored products from an end-user, means for electronically importing details of the order into an order file on the computer, means for relating order details in the order file to stored product information in the stock file on the computer, means for generating a delivery order notice on the computer, means for issuing the stored product with the delivery order notice from the storage means, means for transporting the issued product to the end-user, the transporting means having a mobile communication system, means for installing the details from the delivery order notice into the communication system and means for updating the stock file and/or the order file on the computer from the mobile communication file once the issued product has been delivered to the end-user.

51. An apparatus as claimed in Claim 50 wherein the transporting means comprises a refrigeration vehicle including: (a) a refrigeration area operable within a required temperature range by at least two refrigeration units, a first refrigeration unit operable by the vehicle's power supply and a second refrigeration unit operable by both a battery and mains electrical supply, (b) at least one detection probe for monitoring the temperature of the refrigeration area, (c) a monitoring unit for recording and displaying the temperature data from the detection probe, and

(d) an alarm unit is triggerable when the temperature of the refrigeration area reaches a pre-set minimum or maximum temperature on the monitoring unit.

52. An apparatus as claimed in Claim 50, wherein the first refrigeration unit comprises a primary refrigeration unit and the second refrigeration unit comprises an auxiliary refrigeration unit.

53. An apparatus as claimed in Claim 51 or Claim 52, wherein the detection probe comprises a plurality of air-temperature probes and at least one product probe.

54. An apparatus as claimed in Claim 53, wherein the product probe comprises a temperature probe packaged as a product and placed in a product container thereby mimicking a real product.

55. An apparatus as claimed in any one of Claims 51 to 54, wherein the alarm unit comprises at least one alarm triggerable when the temperature of the refrigeration area reaches the pre-set minimum or maximum temperature within the required operable temperature range.

56. An apparatus as claimed in Claim 55, wherein the alarm unit is triggerable when the temperature of the refrigeration area reaches within 1°C above the minimum temperature within the required temperature range or 1°C below the maximum temperature within the required temperature range.

57. An apparatus as claimed in Claim 56, wherein the alarm unit comprises a second alarm which is triggerable when the temperature of the refrigeration area reaches the minimum temperature within the required temperature range or the maximum temperature within the required temperature range.

58. An apparatus as claimed in Claim 57, wherein the Global Positioning System (GPS) facilitates remote monitoring of the location of the vehicle and facilitates remote monitoring of the analysis from the detection probe.

59. An apparatus as claimed in any one of Claim 50 to 58, wherein the Global Positioning System (GPS) signals the remote computer to temperature spikes and enables a text messages to be sent to a remote site.

60. An apparatus as claimed in any one of Claims 50 to 59, wherein the refrigeration vehicle includes a battery powered heating system.

61. An apparatus as claimed in Claim 60, wherein the battery powered heating system is incorporated into the refrigeration area.

62. An apparatus as claimed in any one of Claims 50 to 61, wherein the refrigeration area is enclosed with a layer or layers of insulation material.

63. An apparatus as claimed in Claim 62, wherein the insulation is readily removable from the refrigeration area.

64. An apparatus as claimed in any one of Claims 51 to 63, including heavy duty insulating barrier strips at the entrance to the refrigeration area.

65. An apparatus as claimed in any one of Claims 51 to 64, wherein the refrigeration units are operable within the preferred range of 2°C to 8°C.

66. An apparatus as claimed in any one of Claims 50 to 65, including a separate ambient section, which includes a heater unit and a refrigeration unit to maintain products at ambient temperatures that is, for example, between 18°C to 25°C.

67. An apparatus as claimed in any one of Claims 50 to 66, including a separate freezer section to maintain products between, for example, -24°C to -30°C.